The American National Red Cross South Carolina Region
Platelets Pheresis Leukocytes Reduced Irradiated
Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed.
Blood product, not prepared in accordance with specifications was distributed.
Blood products, which did not meet acceptable product specifications, were distributed.
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Blood product, collected from an ineligible donor, was distributed.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
B-50 capsules, Healthy Life Chemistry By Purity First, packaged in 100 count bottles, Manufactured for: Purity First Health Products, Inc. dba Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735
Marketed without an Approved NDA/ANDA; product found to contain methasterone and dimethazine which are steroid and/or steroid-like drug ingredients, making it an unapproved new drug
Super-DMZ Rx 2.0 Capsules, 60 count bottles, Dietary Supplement, Lean muscle mass, hardness and strength, Manufactured for Blackstone Labs Boca Raton, FL 33433.
lot numbers: 1) M55Q (A) Exp 04/2016, 2) M55Q (2) Exp 05/16,  3)E07Q  Exp unknown
11,200 bottles (60 capsules per bottle) (quantities for E07Q unknown)
Marketed without an Approved NDA/ANDA; product contains the steroid ingredient 2, 17a-dimethyl-17b-hydroxy-5a-androst-1-en-3-one, making it an unapproved new drug
METHA-DROL Extreme capsules, packaged as 60 capsules per bottle Pro-Anabolic Mass Stack Dietary Supplement, Manufactured for Blackstone Labs, Boca Raton, FL
Marketed without an Approved NDA/ANDA; product found to contain dimethazine which is a steroid and/or steroid-like drug ingredient, making it an unapproved new drug
Worldwide Distribution: US (nationwide): AL, AZ, CA, CT, FL, IL, IN, IA, KY, MD, MA, MI, MS, NV, NH, NJ, NY, PA, WA, and WI; and countries of: AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KUWAIT, LATVIA, NEW ZEALAND, POLAND, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SWEDEN,, SWITZERLAND, TAIWAN, and UNITED KINGDOM.
GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5);   5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5);   5342114-3 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5);   5342114-4 GSI Viewer 1.11 on AW VolumeShare 4 (AW 4.5);   5401757 GSI Viewer 1.20 on AW VolumeShare 3 (AW4.4).  Computed Tomography X-Ray system
When performing a secondary capture generated from GSI Viewer, the header information is correct on the images. However, when changing the ROI (region of interest) and zooming in, the DICOM  header does not change to reflect the new image, thus the line measurements may be inaccurate.
Nationwide Distribution including CA, GA, IN, KY, MD, MI, OH, OK, and WA.
McKesson Anesthesia Care   Product Usage:  The McKesson Anesthesia Care system is a computer based system which collects, processes,and records data both through manual entry and from monitors which themselves are attached to patients, such as in the operating room environment. The system provides clinical decision support by communicating potential Adverse Drug Event alerts proactively during the pre-anesthesia evaluation and at the point-of-care. The system is generally indicated in the anesthetizing environment when the anesthesia provider decides to perform a patient assessment, to generate a paper and/or electronic record of the administration of anesthesia to a patient, and to document care.
There was an occurrence where the patient case data did not match the patient data when the case was recalled in the Anesthesia Care Record (ACR) in that it included data from another case.
TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Computed Tomography X-Ray System; TSX-301A Aquilion One Computed Tomography X-Ray System; TSX-301B Aquilion Premium Computed Tomography X-Ray System; TSX-302A Aquilion Prime Computed Tomography X-Ray System.   This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head. The Aquilion RXL has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.
Toshiba intitiated this recall because their investigation revealed that due to a problem of the X-ray output control software, the X-ray output conditions may not be set correctly. As a result, X-ray exposure under the scan conditions used for contrast study may not start.
AZ, GA, MD, MT, NV, NY, OR, PA, PA, UT, WA, and Washington DC
Blood products, which failed the monthly quality control testing for Factor VIII level, were distributed.
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Estradiol Cypionate 2mg/cc  testosterone cypionoate 50mg
Worldwide Distribution: US (nationwide) including states of: AL, AR, AZ, CA, FL, GA, IL, IN, KS, KY, LA, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, TN, TX, VA, WI, WV and Puerto Rico; and countries of Canada, Espana, France, Ireland, and Slovenia.
*** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA; Y-TYPE BLOOD SET, Nonvented, 88 Inch with 210 Micron Filter Pump, Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira, Inc., Lake Forest, IL 60045 USA;    *** 2) List Number 127200465 labeled in part: 12720-65 LifeShield LATEX-FREE HEMA; BLOOD SET, Nonvented, 81 Inch with 170 Micron Filter, Pump, Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira, Inc., Lake Forest, IL 60045 USA;     *** 3) List Number 046419701 labeled in part: Hospira VENISYSTEMS Blood Bottle Pump Set with CAIR Clamp    Hospira infusion blood sets are intended for the delivery of fluids, including but not limited to, blood and blood products, from a container to a patient's vascular system.
Several lots of the LifeShield Latex-Free HEMA Y-Type Blood Set IV Administration Set were assembled incorrectly.
Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AK, AZ, CA, CT, FL, GA, IL, KY, LA, MD, MA, MI, MO, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SD, TN, TX, VT, VA, WA, WV, WI, and WY, and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czech Republic, Cuba, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan , Panama, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, and Vietnam.
Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators.
During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
distributed in Alaska only and products were sold on www.toniasbiscotti.com
Sampler Bag Biscotti consists of 3 pieces of Almond dipped in Dark Chocolate; 3 pieces of Cranberry dipped in White Chocolate; and 3 pieces of Cranberry & Toasted Almonds.   Sampler Bag is packaged in white windowed paper coated bakery bags and sold under Tonia's Biscotti brand.
Sampler Bag of Biscotti is recalled due to undeclared wheat, soy, and milk.
Lemon Biscotti dipped in White Chocolate Bag, 13 oz., sold in white windowed paper coated bakery bags, And individually wrapped in cellophane - net wt. 2 oz.
Lemon Biscotti dipped in White Chocolate Bag is recalled due to undeclared wheat, soy, and milk.
Cranberry dipped in White Chocolate Biscotti-individually wrapped in cellophane.  Product is sold under Tonia's Biscotti brand, net wt. 2 oz.
Cranberry dipped in White Chocolate Biscotti-individually wrapped is recalled due to undeclared wheat, soy, and milk.
Almond dipped in Dark Chocolate Biscotti-individually wrapped in cellophane.  Product is sold under Tonia's Biscotti brand, net wt. 2 oz.
Almond dipped in Dark Chocolate Biscotti-individually wrapped- is recalled due to undeclared wheat, soy, and milk.
Blueberry drizzled in White Chocolate Biscotti-individually wrapped in cellophane.  Product is sold under Tonia's Biscotti brand, net wt. 2 oz.
Blueberry dipped in White Chocolate Biscotti-individually wrapped is recalled due to undeclared wheat, soy, and milk.
Traditional Toasted Almond Biscotti-individually wrapped in cellophane.  Product is sold under Tonia's Biscotti brand, net wt. 2 oz.
Traditional Toasted Almond-individually wrapped is recalled due to undeclared wheat, soy, and milk.
Alaskan Birch Brittle with Dark Chocolate Biscotti-individually wrapped in cellophane.  Product is sold under Tonia's Biscotti brand, net wt. 2 oz.   Alaskan Birch Brittle Drizzled in dark chocolate-individually wrapped in cellophane.  Product is sold under Tonia's Biscotti brand, net wt. 2 oz.
Alaska Birch with Dark Chocolate Biscotti-individually wrapped is recalled due to undeclared wheat, soy, and milk.
Chocolate Delight dipped in Dark Chocolate Biscotti-individually wrapped in cellophane.  Product is sold under Tonia's Biscotti brand, net wt. 2 oz.
Chocolate Delight dipped in Dark Chocolate Biscotti-individually wrapped is recalled due to undeclared wheat, soy, and milk.
Cran-Almond Biscotti (cranberry & toasted almond) - individually wrapped in cellophane.  Product is sold under Tonia's Biscotti brand, net wt. 2 oz.
Cran-Almond Biscotti (cranberry & toasted almond) - individually wrapped  is recalled due to undeclared wheat, soy, and milk.
Hazelnut Biscotti - individually wrapped in cellophane.  Product is sold under Tonia's Biscotti brand, net wt. 2 oz.
Hazelnut Biscotti - individually wrapped is recalled due to undeclared wheat, soy, and milk.
Mandarin Orange Tozzetti Biscotti - individually wrapped in cellophane.  Product is sold under Tonia's Biscotti brand, net wt. 2 oz.
Mandarin Orange Tozzetti Biscotti - individually wrapped is recalled due to undeclared wheat, soy, and milk.
Worldwide Distribution - USA including AL, CA, CT, GA, FL, IL, IN, KS, KY, LA, MD, MA, MI, MN, MO, NJ, NY, OH, PA, TN, TX, VA, and Internationally to Argentina, Austria, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cuba, Czech Republic, Egypt, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Lebanon, Mexico, Morocco, Netherland, Nigeria, Pakistan, Panama, Peru, Philippines, Portugal, Russia, Serbia, Solvenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, United Kingdom, Venezuela, Vietnam, and Yemen.
RT Desktop   The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Worldwide Distribution: US (nationwide): AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IA, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, including Puerto Rico, DC; and countries of: Albania, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bosnia & Herzego, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Gabon, Germany, Ghana, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Libya, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore Slovakia, South Africa, South Korea, Spain, Sudan Suriname, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, and Vietnam.
Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
US Distribution including the states of: MD, WV, OH, CA, MN, IN, NY and WI.
TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.
Toshiba America Medical Systems, Inc. initiated this recall due to the failure of the parts used in the X-ray high-voltage generator. In some cases, X-ray exposure cannot be performed.
Blood products, collected from a donor who received a tattoo within one year of donation, were distributed.
Blood product, which was incorrectly labeled as leukoreduced, was distributed.
Blood product, collected from a donor who was taking the medication Avodart, was distributed.
Rise N Roll and Amish Wedding Nutty Crunch and Crunch N Nutter  Distributors in PA, OH, WI, NJ, and retail PA, IL, KS, MI, OH, WI, IN, MN, MO, VA;  Product also sold on the website  www.risenrollbakery.com   Bakery products sold in retail stores in Indiana.
Rise n Roll Bakery & Deli, White Powdered Donuts, sold individually and  found in 6 count (436 g) UPC Code 6 26570 61744 0  or 12 count (861.83 g) UPC Code 6 26570 617457,    variety donut box identifying all donut varieties:  White Powdered Donut : Enriched wheat flour, soybean oil, dextrose, salt, leaving, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E)  COATING:  Dextrose, cornstarch, partially hydrogenated vegetable oil, titanium dioxide, rice flour, hydrogenated cottonseed oil, artificial flavor, silicon dioxide.    Contains wheat, soy and milk
Rise n Roll Bakery & Deli, Chocolate Donuts, sold individually and  found in 6 count (436 g) UPC Code 6 26570 61744 0  or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties    Chocolate Donuts  Enriched wheat flour, soybean oil, dextrose, salt, leaving, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E)     TOPPING:  Powdered sugar, butter (milk), chocolate drops (sugar, cocoa butter, chocolate liquor), cocoa powder, flavor salt.    Contains wheat, soy and milk
Rise n Roll Bakery & Deli, Bavarian Creme Donuts, sold individually and  found in 6 count (436 g) UPC Code 6 26570 61744 0  or 12 count (861.83 g) UPC Code 6 26570 617457,    variety donut box identifying all donut varieties    Bavarian Creme Donuts  Enriched wheat flour, soybean oil, dextrose, salt, leaving, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E)     FILLING: High fructose corn syrup, sugar, food starch modified, palm oil, salt, titanium dioxide, agar sorbic acid, sodium benzoate, potassium sorbate, artificial flavor, modified cellulose, propylene glyocol, glycerin, corn starch, dextrose, polysorbate 80 & 60, sorbitan monostearate, sodium citrate, xanthangum, annatto, caramel color, yellow 5, yellow 6.     Contains wheat, soy and milk
Rise n Roll Bakery & Deli, Apple Fritter, sold individually and  found in 6 count (436 g) UPC Code 6 26570 61744 0  or 12 count (861.83 g) UPC Code 6 26570 617457,   variety donut box identifying all donut varieties    Apple Fritter  Enriched wheat flour, apples, soybean oil, dextrose, cinnamon, salt, leavening, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E)     GLAZE: Powdered sugar, conrnstarch, modified foodstarch (corn) and milk.     Contains wheat, soy and milk
Rise n Roll Bakery & Deli, Caramel Donuts, sold individually and  found in 6 count (436 g)UPC Code 6 26570 61744 0  or 12 count (861.83 g) UPC Code 6 26570 617457,   variety donut box identifying all donut varieties    Caramel Donuts  Enriched wheat flour, soybean oil, dextrose, salt, leaving, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E)     TOPPING:  Powdered sugar, brown sugar, butter (milk), salt    Contains wheat, soy and milk
Rise n Roll Bakery & Deli, Cinnamon Caramel Donuts, sold individually and  found in 6 count (436 g) UPC Code 6 26570 61744 0  or 12 count (861.83 g) UPC Code 6 26570 617457,  variety donut box identifying all donut varieties and in Cinnamon Caramel Donut Holes, 1.05 lb, UPC Code 6 26570 61743 3. Cinnamon Caramel Donuts, donut holes  Enriched wheat flour, soybean oil, dextrose, salt, leaving, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E)     TOPPING:  Powdered sugar, brown sugar, butter (milk), dextrose, cornstarch, cinnamon, palm and soy oil, salt and flavor.    Contains wheat, soy and milk
no codes, manuactured 1/13/2014 or before
Rise n Roll Bakery & Deli, Glazed Donuts, sold individually and  found in 6 count (436 g) UPC Code 6 26570 61744 0  or 12 count (861.83 g) UPC Code 6 26570 617457,   variety donut box identifying all donut varieties    Glazed Donuts  Enriched wheat flour, soybean oil, dextrose, salt, leaving, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E)     GLAZE:  Powdered sugar, cornstarch, modified foodstarch (corn) and milk.    Contains wheat, soy and milk
Rise n Roll Bakery & Deli, Raspberry Creme Donuts, sold individually and  found in 6 count (436 g) UPC Code 6 26570 61744 0  or 12 count (861.83 g) UPC Code 6 26570 617457,  variety donut box identifying all donut varieties    Raspberry Creme Donuts  Enriched wheat flour, soybean oil, dextrose, salt, leaving, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E)     FILLING:  Black raspberries, granulated sugar, permaflo, lemon juice and natural flavor.    Contains wheat, soy and milk
No codes, manufactured 1/13/2014 or before
Undeclared egg ingredient and undeclared Yellow # 6 and Yellow #5
A.    Rise n Roll Specialties, Homemade, Nutty Crunch, ..., boiled to perfection, NT. WT 8 oz.,   ING cashews, pecans, almonds, butter (milk) sugar. Contains Nuts and Milk. UPC Code 8 27912 04158 3    B  Simply Amish, Crunch N Nutter, Mixed Nut,... No Preservatives, ...NT. WT 4 oz.  Ingredients: cashews, pecans, almonds, butter (milk) sugar. Contains Nuts, Milk, and Soy, Merrell Food Group, Inc., Dalton, WI 53926  UPC#861522000042.
Rise N Roll, Nutty Crunch Best by date June 13th, 2014 or earlier Simply Amish, Crunch N Nutter, Best by date of June 1, 2014 or earlier;
Amish Wedding, Nutty Crunch, ... boiled to perfection,  Distributed by Troyer Cheese, Inc. ... Millersburg, OH 44654, NT. WT 8 oz.,   ING cashews, pecans, almonds, butter (milk) sugar. Contains Nuts and Milk. UPC Code 8 27912 04158
a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Dist by Walgreen Company, 200 Wilmot RD Deerfield IL 60015 b) Family Wellness Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Distributed by Family Services Inc .10401 Monroe Road, Matthews, NC 28105 USA  c) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 14 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895  d) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 28 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895  e) Equate Lansoprazole Delayed-Release Capsules USP, 15 mg Acid Reducer, 14 capsules per Bottle, and 28 capsules per bottle (Twin Pack)Distributed by Wal-mart Stores Inc. Bentonville, AR 72716  f) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 42 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895
Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count were observed at the initial stability interval for Lansoprazole Delayed Release Capsules.
Blood products, for which the testing for pH was invalid, were distributed.
Blood products, collected from a donor who did not have a complete physical examination, were distributed.
Blood Center of Northcentral Wisconsin, Inc.
Blood product, with a low platelet yield, was distributed.
Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11, 25 vials in tray, each boxed vial individually labeled as: Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11.
Lot Number: 6004137, Expiration date: 06/2014
US States: CA, IL, MI, WI, PA, VA, CT, MA, NY, AL. International: Canada, Bulgaria, Saudi Arabia, United Kingdom & Ireland, France, Germany, Greece, Italy, Lithuania, Czech Republic, Romania, Serbia, Austria, Netherlands, Spain, Peru.
Lambda Cell Tray'' Cell Panels, Article Number: LCT-TRAY-PI, Rev 14.   BK840013.
Catalog Identification: LCT1W30 (Lots 26, 27);  LCT1W60 (Lots 26, 27);  and LCT1W72 (Lots 3, 4).  Article Number: LCT-TRAY-PI, Rev 14.
One Lambda, Inc., part of Thermo Fisher Scientific, is conducting a correction of Lambda Cell Tray'', because the product insert for Lambda Cell Tray products (document identification LCT-TRAY-PI-EN-00, Rev 14), contains a documentation error. In the product insert, line 2 in the Directions For Use section is mistakenly repeated. The  documentation error in the protocol may cause an end user to incorrectly perform a second incubation and wash off the product. This  duplication may result in additional cell loss during the washing procedure.
Horiba Instruments, Inc dba Horiba Medical
ABX PENTRA Multical. ABX PENTRA N Control.  ABX PENTRA P Control.    The ABX PENTRA 400 and PC200 are benchtop clinical chemistry analyzers using two  measuring principals: absorbance and ion selective electrodes.  The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical  additives and materials of biological origin. The assigned values of the calibrator  components are given in the enclosed annex, ensuring optimal calibration of the  appropriate HORIBA ABX SAS methods on the ABX PENTRA Clinical Chemistry  Analyzer. This calibrator is provided in ten vials of 3 ml.
Model Numbers:Multical - A11A01652, N Control - A11A01653,  P Control - A11A01654.    Lot Numbers: MultiCal: 1204101 and 1304901,  N Control: 1300801,  P Control: 1300601.    Expiration Date (s): MultiCal: 1204101 Expires on 05/31/14,  MultiCal: 1304901 Expires on 07/15/15,  N Control: 1300801 Expires on 11/05/14,  P Control: 1300601 Expires on 11/05/14.
HORIBA Medical is informing all ABX PENTRA MultiCal, N Control, and P Control customers running the Creatinine Rate Blank Method assay on the ABX PENTRA 400 and PC200 that the Target Values for Creatinine Rate  Blank Method have been updated. This issue is only applicable to Creatinine Rate Blank Method values reported on the  ABX PENTRA 400 and PC200 Chemistry Analyzers only. No other analyzers or other analyte values are affected.
Worldwide Distribution: USA (nationwide) and the country of Canada.
Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 -- Made in France -- TROPHY 77435 Marne La Vallee --- COMMON/USUAL NAME:  Dental X-Ray Systems -- CLASSIFICATION NAME:  Unit, X-Ray, Extraoral  with timer --- There are four major components:  x-ray tube, x-ray generator, collimator and image receptor.  These systems are permanently installed diagnostic dental x-ray systems for generation of x-rays for examination of the teeth, jaw and oral structures.
Serial Numbers starting with WE, WF, WG, WH, WI, WJ, WK, WL, XA, XB, XC, XD, XE, XF, XG, XH, XI, XJ, XK, XL, YA, YB, YC, YD
Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage.
Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 5303151, XR-5154323 -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 -- Made in France -- TROPHY 77435 Marne La Vallee --- COMMON/USUAL NAME:  Dental X-Ray Systems -- CLASSIFICATION NAME:  Unit, X-Ray, Extraoral  with timer --- There are four major components:  x-ray tube, x-ray generator, collimator and image receptor. These systems are permanently installed diagnostic dental x-ray systems for generation of x-rays for examination of the teeth, jaw and oral structures.
Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028    The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-ann Imaging System is compatible with certain Image Guided Surgery Systems.
Review of on-system electronic product labeling and Instructions for comply with applicable Use in response to a customer inquiry uncovered gaps in compliance FDA standards with the requirements for information to be provided to users in 21CFR 1020.30(h)
Worldwide Distribution-USA (nationwide) and the countries of  Australia, Great Britain, Canada and Japan.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0.   Indicated for primary implantation for the visual correction of aphakia in adult patients.
Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power.
Worldwide Distribution - USA including CA, IN, KS, MA, NJ, TN,TX,UT and Internationally to Australia,  Austria,  Belgium, China,  France,  Germany,  Greece,  Ireland,  Italy,  Japan,  Luxembourg,  Netherlands,  Norway,  South Korea,  Spain, Sweden,  Switzerland,   Taiwan,  United Kingdom.
Greatbatch Medical, Offset Cup Impactor.   The Standard Offset Cup Impactor is a reusable instrument used during acetabular replacement surgery to implant an acetabular cup. The Standard Offset Cup Impactor is provided non-sterile and must be sterilized prior to use in a surgery. The Standard Offset Cup Impactor is used to implant cups during many minimally invasive surgical approaches to Total Hip Arthroplasty ( ri-IA).
Greatbatch Medical has initiated a global Field Corrective Action for the Standard Offset Cup Impactor since the product was first released in 2004.   Greatbatch has identified through internal Sterility Assurance Level validation testing that a sterility assurance level of 10-6 is not achieved on the Standard Offset Cup Impactor when it is subjected to the steam sterilization cycles and associated dry times that are specified in the current Instructions For Use (IFU) provided with the device. The Standard Offset Cup Impactor is provided non-sterile and must be sterilized prior to use in a surgery. Greatbatch has not received any reports of deaths, illnesses, injuries, or other adverse effects associated with this issue.
Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA., NDC 0555-0923-02.
CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation.
Teva Hydroxyzine Pamoate Capsules, USP, 100 mg, 100- count bottle,Rx only, Distributed by Teva Pharmaceuticals USA, Sellersville, PA. NDC 0555-0324-02
CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.
Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg (mixed salts) , 100 count-bottle, Rx Only,  Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0972-02.
CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the finished product was not properly quarantined as rejected due to inadequate cleaning of equipment.
Teva Hydroxyzine Pamoate Capsules, USP, 25 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0323-02.
CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.
Punch Hair Matic   A surgical hair transplant device designed for automation of follicular transplantation.
Medicamat is initiating a field correction due to misbranded marketing literature for the Punch Hair Matic SAFER.
Worldwide Distribution - USA (nationwide) including the states of  AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, NS, NO, NE, NH, NH, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI and WY., and the countries of : AUSTRALIA, CANADA, AUSTRIA, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, CHILE, CHINA, COSTA RICA, CYPRUS, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, INDIA, INDONESIA, JAPAN, MALAYSIA, MEXICO, NAMBIA, NETHERLANDS, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, SWEDEN, TAIWAN, THAILAND, TURKEY, UNITED KINGDOM, SERBIA AND YUGOSLAVIA.
GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feature enabled.   The Solar 8000i with Patient Data Module / Transport Pro with Patient Data Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional medical facility, such as hospital, clinic, surgical center or doctor's office. It can be used in multiple areas such as operating room (OR), post anesthesia care unit (PACU), emergency department (ED), chest pain clinic, general intensive care unit (ICU), critical care unit, surgical intensive care unit (SICU), respiratory intensive care unit, coronary care unit (CCU), medical intensive care unit (MICUI, pediatric intensive care unit (PICU), or neonatal intensive care unit (NICU). The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the PDM includes ECG, invasive pressure, non-invasive blood pressure, pulse oximetry, temperature, cardiac output and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes. The Transport Pro patient monitor is intended for use as part of a transport monitoring system for intra-healthcare facility transport. When used with the Patient Data Module (PDM) or the TRAM acquisition module, this device is intended to provide uninterrupted monitoring of physiologic parameter data for adult, pediatric, and neonatal patients during transport from one area of the healthcare facility to another. Physiological parameter data includes ECG, invasive pressure, noninvasive blood pressure, pulse oximetry, temperature and respiration. Both th
GE Healthcare has recently become aware of a potential safety issue with the Solar 8000M/i Patient Monitor Automatic-View-On-Alarm (AVOA) feature.   The Solar 8000M/i AVOA feature will stop functioning if the patient monitor is discharged from the CIC Central Station while a remote automatic bedside alarm view is currently being displayed on the Solar. Once this issue occurs, subsequent remote AVOA alarms will not automatically appear on the left side of the Solar display. In addition, the user interface menus on the discharged patient monitor will not function correctly. This may result in delayed treatment due to missed alarms that may be serious.
IL, MA, NJ & NY; Canada, Mexico, Denmark, Costa Rica
Deb-El Foods Dried Whole Eggs Deb El Food Products LLC 2 Papetti Plaza, Elizabeth, NJ 07206
Deb-El Food Products LLC is recalling dried whole eggs due to undeclared milk.
Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCl 5 mg) per 5 mL, 8 FL OZ (237 mL) bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR  72716, NDC 49035-229-08, UPC 6 81131 03884 3.
Presence of Precipitate: Recall is due to complaints of a white substance, confirmed as Guaifenesin, an active ingredient in the product which is precipitating out.
Worldwide Distribution:US (nationwide) and to countries: Australia, Netherlands, United Kingdom, Spain, Germany, France, Denmark, Switzerland, Poland, Slovak Republic, Austria, and United Arab Emirates.
Accessory shorts for the AlterG Anti-Gravity treadmill.   Use with the AlterG Anti-Gravity Treadmill for rehabilitation.
Product M320, Accessory Shorts with lot numbers XIN1212 and XIN0413.
Unapproved material used by vendor in subset of shorts causing them to stretch more than usual and are uncomfortable for patient.
Worldwide Distribution: US (nationwide) and to countries of:Canada, Sweden, Belgium, Spain, Portugal, Slovenia, and Israel.
Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Model Number MOL2650.
Focus Diagnostics initiated the recall of the certain Simplexa Flu AlB & RSV Direct assay kits due to  the potential of false positive Flu A, Flu B and RSV signals.
US Distribution to states of: NJ, AL, TX, WA, IL, OK, VA, FL, OR, and KS.
DeRoyal(R) ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack,  Rx Only STERILE EO, distributed by DeRoyal Industries, 200 DeBusk Lane, Powell, TN  37849
Three lots of circumcision clamps were manufactured out of specification and as a result may not properly clamp at  the surgical site completely.
Nationwide distribution including AZ, FL, HI, OH, MI, NC NH, WA, TX, WI, OK, CA, RI, LA, ID, IL, IN, and TN.
Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). The Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In Restoris MCK combination where multi-compartmental areas are being treated, the Restoris MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere. Is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces.
The product may be mislabeled and could result in the incorrect implant being used.
PRE1001:  Prevena Peel and Place System Kit   Product Usage:  The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
PRE1001US:  Prevena Peel and Place System Kit (US-ONLY)   Product Usage:  The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
PRE1055: Prevena Dressing, 5 Pack   Product Usage:  The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
PRE1055US: Prevena Dressing, 5 Pack (US-ONLY)   Product Usage:  The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
PRE2001: Prevena Incision Management Customizable System Box   Product Usage:  The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
PRE2055: Prevena Customizable Dressing 5-Pack   Product Usage:  The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY)   Product Usage:  The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY)   Product Usage:  The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
Worldwide Distribution: US (nationwide) and to countries of: Canada, Ireland, and United Kingdom.
MEDITECH Microbiology - Calculator/data processing module, for clinical use.
Model, catalogue, or product order number(s): MAGIC Releases 5.6, 5. 5.66 and Server Releases 5.6, 5.65. 6.0, 6.05, 6.06, 6.07, 6.1 and 6.13.
Potential for patient results being removed from LAB/EMR.
Whole (round) Tomatoes packed in cardboard boxes of 20 and 25 lbs each.
Nationwide Distribution - USA including TX, LA, FL, CA, and AZ.
FMP X-alt Acetabular Liner   This acetabular liner is intended for use with DJO Surgical hip systems. It is used with an acetabular shell to replicate the kinematics of a natural hip.
Model/Catalog Number 931-28-248 Lot/Serial Number 685F1034 (an MP5 Non-Hooded, Neutral Liner)   were mistakenly packaged/labeled as    Model/Catalog Number 932-36-252, Lot# 728F1089 (an MP7 10-degree Hooded Liner)    and vice-versa
10 units of Model/Catalog Number 931-28-248 Lot/Serial Number(s) 685F1034 labeled asModel/Catalog Number 932-36-252, Lot# 728F1089
Packaging error -- two different types and sizes of acetabular liners used during hip replacement surgery were mistakenly packaged into each other's outer boxes after sterilization, resulting in the products being mislabeled.  The units labeled as Model/Catalog Number 931-28-248 Lot/Serial Number 685F1034 on the outside and containing Model/Catalog Number 932-36-252, Lot# 728F1089 on the inside (10 units)were not distributed.  The units labeled as Model/Catalog Number 932-36-252, Lot# 728F1089 on the outside and containing Model/Catalog Number 931-28-248 Lot/Serial Number 685F1034 on the inside (10 units) were distributed.
USA Nationwide Distribution in the states AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MI, MN, MO, MS, NC, ND, NE, NM, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV
BencoDental tartar & stain remover ultrasonic cleaning solution   Product Usage:  Formulated especially for removal of calculus, tartar, tobacco and food stains from dentures, bridges, orthodontic appliances, etc. Use also for removal of permanent cement.
As the result of a complaint to Heraeus Kulzer's customer service department, Heraues Kulzer is recalling Benco Tartar and Stain Solution part #1010-451, lot #13121434 because it has incorrect labeling on the immediate container.  While the outer carton correctly states ''Benco Tartar and Stain'', the immediate gallon container in which the solution is contained incorrectly states ''Benco Temporary Cement Remover''.
An ingredient used to manufacture the product  tested positive for Salmonella
Heart of the Valley brand Parsnips, produce of U.S.A.,  packaged in the following sizes: 16 ounces (453 grams), UPC 31446-22016;  20 ounces (566 grams), UPC 31446-22020; 20 lb. bags; and 40 lb boxes
Parsnips were found to be above tolerance, maximum residue level, for the pesticide linuron.
Nationwide in US and worldwide to EU, Australia, and Russia
Wet Nuru Massage Gel, Nuru Original, Net Wt. 8.8 oz and 38 oz.
Wet Nuru Massage Gel, Nuru Concentrate, Net Wt. 8.8 oz and 38 oz.
Shipped to distribution centers in Florida
18 lb box of  Curly Parsley packaged in 3 wire wooden crates
Sample of Parsley was found positive with Salmonella.
Nationwide Distribution including GA, CA, TX, MO, OH, PA, WA, AL, IN, AZ, MI, IA, TN, KY, NC, VA, NY, LA, IL, UT, and KS.
Synthes 5.0mm Variable Locking Screw   This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plate shaft.The variable angle Combi hole provides the flexibility of axial compression and variable locking capacity throughout the length of the plate shaft.
Labeling correction: The package insert in one 5.0mm Variable Locking Screw package was a GP0006 (Anterior Cervical Vertebrae Plate System) insert, which should have been a GP2848 (4.5mm VA-LCP Curved Condylar Plate System insert).
Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, Rx only,  Manufactured by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-3086-06, UPC 3 0228-3086-06 2.
Failed Dissolution Specifications: Product did not meet specification requirements for dissolution.
Distributed directly in the following states: AZ, CA, FL, NV, PA, TX, WA, and WI.
Bakes Sea Salt Potato Chips, Kettle Brand, Item 07-10982-000.  It is packaged in a 4 oz. retail bag, 15 bags per case.   Bag UPC 84114 10984 2.  Case UPC 84114 10982 5.
Best By Date: 01MAY14.   Case Manufacturing Code: 09309210 05:00 through  09309210 10:30    05:00 and 10:30 represent 5:00 am-10:30 am - production time stamp.
Kettle Foods, Inc. is recalling Bakes Sea Salt Potato Chips, Kettle Brand, due to potential undeclared milk.
Chocolate Ice Cream manufactured under the Dairy Rich brand and packaged in a 1.75 quart (1.66 L) (56 oz.) carton.
This voluntary recall has been initiated because Dairy Rich Chocolate Ice Cream may contain peanut butter, which contains a peanut allergen.
Colorado and NM. No foreign, military/govt,VA consignees.
Falafel King Green Chile Hummus, 10 oz, Plastic Tub, packaged in 12count and 8 count cases. Labeled in part ** Falafel King  green chile   hummus  GF  100% NATURAL**
Falafel King is recalling their Green Chile Hummus because the green chile topping was recalled by Bueno Foods for Listeria Monocytogenes.
Falafel King Green Chili Hummus Wrap, 8.5 oz individual packages of the Green Chili Hummus Wraps
US Distribution including the states of  IL, MA, KS, and, NJ.
Triton FP Infusion Pump, Part Number 400000, packaged in boxes.   The Triton Volumetric Infusion Pump is indicated for delivering infusions of medications, as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient Control Analgesia). It is intended for use in hospitals, ambulatory & nursing home (extended care) settings, and home care environments.
WalkMed Infusion is initiaing a recall on their Triton FP Infusion Pump, Part Number 400000 due to the label on the right side of the pump containing an incorrect instruction.
Worldwide Distribution - USA (nationwide) and the countries of  France, Great Britian, China, India, Italy, Korea, Kuwait, Nehterlands, and Singapore.
Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator. Trilogy 200 Intended Use: The Respironics Trilogy 200 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 200 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. Trilogy 202 Intended Use: The Respironics Trilogy 202 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation with or without air/oxygen blending. Trilogy 202 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in hospitals and institutions, and for portable applications such as wheelchairs and gurneys only when in an institutional setting. It may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.
Internal testing revealed a potentially defective component on the power management board that could affect the function of certain Trilogy Ventilators resulting in loss of therapy to patients.
Worldwide Distribution: USA (nationwide) including the states of AZ, CA, CO, FL, GA, IL, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, SC, TX, UT, and WI, and the country of Canada.
Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe.
Product Number: MIH-3333;  NDC Number: 64253-333-33;   Lot Numbers and Expiration Dates: Lot H114120N, Expires 12/15; Lot H113403N, Expires 11/15; Lot H113369N, Expires 10/15; Lot H113327N, Expires 8/15; Lot H113291N, Expires 7/15; Lot H113266N, Expires 6/15; Lot H113232N, Expires 5/15; Lot H113185N, Expires 3/15.
The bar code that is printed on the Master Carton label does not correspond to the product code fully displayed on the Master Carton label. The non-matching information can only be detected by using a bar code reader. The defective bar codes will be read as Product No. MIH-3335 ( Heparin I.V. Flush Syringe 100 units/mL; 5 mL fill in 12 mL Syringe) whereas this product is actually Product No. MIH-3333 (Heparin I.V. Flush Syringe 100 units/mL; 3 mL fill in 12 mL Syringe).
Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free Vial, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1162-02
Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial.
University Of Miami Miller School of Medicine Tissue Bank
Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed.
0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09
Lack of Assurance of Sterility:Solution leaking through the port cover of the primary container, which was identified during a retain sample visual inspection.